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AVANOS 94842Recalls & reported problems

Avanos Medical, Inc. · MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770948423), received between Apr 26, 2024 and Apr 26, 2024 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Cellulitis2
  • Drug Resistant Bacterial Infection2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED, THE PATIENT HAD A 14 FR X 1.5 CM FEEDING TUBE AND DEVELOPED SIGNIFICANT CELLULITIS WITH METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE PATIENT HAD TO BE ADMITTED AFTER TWO ROUNDS OF ORAL ANTIBIOTICS.

    Patient problems: Cellulitis; Drug Resistant Bacterial Infection

    MAUDE report 19192347 ↗
  • InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED, THE PATIENT HAD A 14 FR X 1.5 CM FEEDING TUBE AND DEVELOPED SIGNIFICANT CELLULITIS WITH METHICILLIN-SENSITIVE STAPHYLOCOCCUS (MSSA).

    Patient problems: Cellulitis; Drug Resistant Bacterial Infection

    MAUDE report 19192320 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.